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Subject:
From:
Douglas Pauls <[log in to unmask]>
Reply To:
TechNet E-Mail Forum <[log in to unmask]>, Douglas Pauls <[log in to unmask]>
Date:
Thu, 26 May 2016 10:14:39 -0500
Content-Type:
text/plain
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text/plain (63 lines)
Chicken.

I agree with what Dave said, at a high level.  But where it gets to the
headache part is: what is the burden of proof or how much data is needed to
demonstrate that you do not affect form fit or function.

Everything I have seen so far leaves it pretty much at the discretion of
the Subject Matter Experts (SMEs), which leaves a lot of room to play.
Maybe we need a lot of room to play.


Doug Pauls
Principal Materials and Process Engineer
Rockwell Collins

On Thu, May 26, 2016 at 10:11 AM, Stadem, Richard D. <
[log in to unmask]> wrote:

> It is pretty subjective, and it gives me a headache to think about it, so
> I am going to take the easy way out and agree with Hillman.
>
> -----Original Message-----
> From: TechNet [mailto:[log in to unmask]] On Behalf Of Douglas Pauls
> Sent: Thursday, May 26, 2016 10:00 AM
> To: [log in to unmask]
> Subject: [TN] How much change is change?
>
> Good morning all,
>
> One of the IPC groups that I am leading is presently wrestling with the
> issue of minor vs. major change.  Generally along the lines that if you
> have a baselined or qualified manufacturing process, how much can that
> process change before it needs to be re-baselined or re-qualified?
> Sometimes this is referred to as Level 1 vs. Level 2 change.
>
> So far, every quality documentation system that I have looked at, like
> AS9100, ISO9000, etc., gets really fuzzy and uses vague terms when you
> approach this issue.  Most of these documentation systems have change
> better defined for products, but get extremely fuzzy and extremely vague
> about manufacturing processes.
>
> This forum has a lot of very smart, very experienced people. How would you
> differentiate a minor change, which would not impact form fit or function,
> from a major change, which "could/would" impact form fit or function?
>
> And I want all you lurkers to come out of the woodwork on this one.
>
> Doug Pauls
> Principal Materials and Process Engineer Rockwell Collins
>
>
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